Documentation Specialist

Details:
Stefanini Group is hiring!
Stefanini is looking for Documentation Specialist in Round Lake, IL
For quick Apply, please reach out to Bhavishya Yagnik - call: / email:
Work Hours: M-F (40 hours)
Work Location: Round Lake, IL
Shift: 1st Shift
This position reports to the Manufacturing functional areas. This position provides Manufacturing documentation review. Review the batch record or any other GMP document to ensure compliance with cGMP, Company Policies and local SOPs.

• Supporting manufacturing's batch documentation review.
• Responsible for ensuring manufacturing's batch records meet specifications and submitted to Quality per release schedule
• Assure batch documentation complies with GDP standards.
• Determine acceptability by using specifications and standard operating procedures.
• Ensure presence of all required documentation prior to the submission of batch folder to Quality.
• Maintain files such that documents are readily available and easily retrievable.
• Initiate and close GME work orders.
• Author Non-Conformance Records (NCRs) and Exceptions Investigations
• Author TCU documentation changes including revisions, periodic reviews and GAP assessments
• Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary.
• Use SYSTECH to review and approve counts for batches.
• Initiate batch folders by performing necessary data entry.
• Support GME cycle counting as needed
• Other administrative duties as assigned.

Job Requirements
Details:

• Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.(Required)
• Strong computer skills in MS Office Suite.
• Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
• Strong attention to detail.
• Individuals will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks.
• Ability to communicate efficiently verbally and in writing with all levels of the organization.
• Identify areas for continuous improvement.
• Individuals must be willing to adjust work hours and work overtime based on business needs.
• Must be able to lift 30 pounds.
• Must not be allergic to Penicillin or Cephalosporin drugs.

Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
Pay Range:
$ 22.00 - $ 25.50